# K151383: NeuViz 128 Multi-slice CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Nov 4, 2015 after 166 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 6.

## Most influential descendants
- K230220: NeuViz 128 Multi-Slice CT Scanner System (2023), 0 descendants of its own
- K171201: NeuViz Prime Multi-slice CT Scanner System (2017), 0 descendants of its own

## Recalls of this device
- Jan 9, 2019 · Class II · Z-0773-2019: For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan w
- Oct 22, 2018 · Class II · Z-1280-2019: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the co
- May 19, 2017 · Class II · Z-3045-2017: Software defect

## Indications for use
The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Source page: https://510kreport.com/device/K151383
Methodology: https://510kreport.com/methodology